Safety and Efficacy Study of Pirfenidone to Treat Grade 2 or Above Radiation-induced Lung Injury

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02296281

Enrollment

Registered

2014-11-20

Start date

2015-01-31

Completion date

Unknown

Last updated

2014-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiation Pneumonitis

Brief summary

The purpose of this study is to assess the safety and efficacy of pirfenidone capsules to treat grade 2 or above radiation-induced lung injury patients.

Interventions

DRUGPirfenidone

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. 18-70 years old (include 18 and 70 years), male or female 2. The pathological diagnosis of lung cancer, with non-small cell lung cancer (NSCLC) staging IIIA or IIIB, and small cell lung cancer (SCLC) in council deadline 3. General condition assessment, ECOG score of 0-1 4. Enough heart, liver and kidney function, such as AST, ALT, LDH≤2 times ULN such as plasma total bilirubin, creatinine ≤1.5 times ULN; hematopoietic function enough, such as neutrophils ≥4.0 x109 / L, platelets ≥100 x109 / L 5. The expected survival at 6 months or more 6. Subject is able to eat solid food 7. The initial radical thoracic radiotherapy treatment 8. The clinical diagnosis of radiation-induced lung injury in Grade 2 or above 9. The duration of radiation-induced lung injury in less than 1 month 10. Signed informed consent

Exclusion criteria

1. Radiation-induced lung injury has entered the chronic phase 2. A history of chronic bronchitis, emphysema, or a history of cor pulmonale 3. Lung resection surgery 4. Cancer progression 5. Pulmonary infection 6. Associated with other serious diseases: such as occurred within 6 months of myocardial infarction, uncontrolled diabetes etc. 7. With active peptic ulcer 8. Pregnant women and patients with mental disease 9. Those who participate in clinical trials of other drugs within 3 months 10. Investigator judge does not apply to participate in the trial

Design outcomes

Primary

Measure	Time frame
Changes in radiation-induced lung injury classification	36 Weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026